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GCP Auditor


  • Robsco Search
  • 07/10/20
  • Jersey City, NJ
  • 07310
  • Contractor
The GCP Auditor serves as an in-house expert on audit-related matters, maintaining an up-to-date awareness of internal programs and external trends. The incumbent will perform a broad range of audit-related duties (e.g., planning audits, performing audits, providing QA project management, ensuring follow-up on findings, providing formal reports, and collaborating with global colleagues as needed on projects).
Responsibilities:
Maintains keen awareness of all audit-related matters (e.g., internal clinical program status, SOPs and other internal guidance, regulatory changes, industry trends):
Possesses an awareness of current and planned clinical programs within.
Performs QA project management to deliver agreed QA coverage of projects and activities related to assigned compound(s)
Actively provides QA input toworking groups and system(s) development as appropriate
Provides advice on QA and GCP matters to staff
Serves as primary liaison with Regulatory Affairs Dept in maintaining an awareness of ongoing regulatory changes
Attends relevant conferences and seminars to maintain awareness of external QA activities
Delivers the QA contribution to internal and external meetings (e.g. investigator meetings) as appropriate
As requested, develops QA SOPs
Provides QA review and approval ofSOPs and Work Instructions
Reads and maintains awareness of applicableSOPs relevant to function
Performs wide-ranging audit activities:
Prepares audit plans for clinical and other projects as applicable
Liaises with relevant parties to arrange audits or reviews required by QA audit plans
Performs audits ofinternal systems
Prepares reports of audits performed, per SOP(s) timelines
Follows up on audit observations to agreed conclusions
Provides audit certificates for relevant audits
Distributes relevant audit reports and documents in accordance with QA Policy
Liaises as required with internal/external counterparts on global activities and programs:
Provide local US perspectives in relation to global activities and systems
Liaises as required with QA representatives in other markets
Hosts "GXP" related audits and inspections
Performs other duties as required
Qualifications:
Bachelors degree (science major is preferred)
At least seven (7) years experience as a QA Auditor of the drug development process
In-depth experience with Good Clinical Practices (e.g., leading GCP audits and/or training staff in GCPs) is required
Highly analytical and detailed approach; proven ability to detect and correct errors and/or inconsistences
Comprehensive understanding of FDA regulations; knowledge of ICH guidance is required
Excellent interpersonal and communication skills; ability to build effective relationships within a team/collaborative environment, while demonstrating a high level of professionalism
Good written communications skills, including SOP/other technical writing
Able to travel as required within a global work environment (approximately 10%)
Physical Demands:
Ability to sit or stand for long periods of time
Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
Ability to carry, handle and reach for objects
Ability to lift and pull up to 15 pounds

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